Systems Validation Lead

The Systems Validation Lead is responsible for the qualification and validation of GxP-relevant IT systems and equipment at Cellistic, ensuring compliance with data integrity and regulatory requirements. This role supports users, IT, and QA in system lifecycle management, from procurement to retirement, and acts as the central point of expertise for Computerised System Validation (CSV). The Systems Validation Lead ensures robust documentation, oversees validation projects, and contributes to continuous improvement of validation practices to secure reliable, compliant, and efficient systems.

Key Responsibilities

System Validation & Technical Expertise

• Participate in procurement processes to anticipate IT integration and qualification needs.
• Support drafting of User Requirements Specifications (URS) and Risk Impact Assessments (RIA).
• Contribute to system and equipment specifications.
• Write, review, and improve qualification protocols (IQ/OQ/PQ).
• Coordinate and participate in equipment installation, commissioning, and training.
• Act as a key contact for system upgrades, repairs, and follow-up on qualification dossiers.

GMP and Regulatory Compliance

• Ensure validation and qualification activities are compliant with GxP, Cellistic QMS, and relevant regulations (e.g., Annex 11, 21 CFR Part 11).
• Perform Data Integrity assessments during qualification and follow up on resulting actions.
• Conduct recurrent Audit Trail Reviews and ensure compliance with data integrity standards.
• Support QA during inspections and audits by providing validation documentation and expertise.

Operational Reliability & Risk Management

• Assess risks related to IT systems and computerised equipment, proposing preventive and corrective measures.
• Ensure validation activities are aligned with system lifecycle management.
• Monitor performance of validated systems and track resolution of validation-related issues.

Project Support & Process Improvement

• Contribute to cross-functional projects requiring system validation or qualification.
• Support digitalisation initiatives and harmonisation of validation practices.
• Propose improvements to validation processes, templates, and tools.

Data & Documentation Management

• Ensure protocols, reports, and SOPs are accurate, up to date, and audit-ready.
• Draft and revise SOPs related to system validation and ensure recurrent review.
• Maintain validation documentation in compliance with GMP and internal quality standards.

Cross-functional Collaboration

• Act as an interface between QA, IT, end-users, and suppliers for validation topics.
• Support training of users on system qualification and data integrity requirements.
• Ensure smooth communication with internal stakeholders and external partners.

Required Qualifications & Experience

• Master’s or Bachelor’s degree in Engineering, Life Sciences, IT, or a related technical field.
• Minimum 5 years of experience in Computerised System Validation (CSV), equipment qualification, or IT/QA functions within GMP-regulated environments (biotech, pharma).
• Strong knowledge of GAMP 5, data integrity principles, and applicable regulatory guidelines (Annex 11, 21 CFR Part 11).
• Proven track record in writing and executing validation documents (URS, protocols, reports, SOPs).
• Experience coordinating system qualification and validation projects in cross-functional settings.
• Working knowledge of IT system lifecycle management and digital tools for validation documentation.

Soft Skills

• Analytical and detail-oriented, with a structured approach to problem solving.
• Strong communication and interpersonal skills, able to work effectively with technical and non-technical stakeholders.
• Pragmatic and hands-on, with the ability to balance compliance and operational needs.
• Organised and capable of managing multiple projects simultaneously.
• Fluent in English; knowledge of French or Dutch is an advantage.
• Comfortable in a dynamic and growing biotech environment.

Interested?

Send your motivation letter with curriculum vitae to: careers@cellistic.com